BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM— 510(k) K895886

Clearance details

Applicant

Biopro, Inc.

Product code

Code KWL

Device class

Class 2

Regulation

21 CFR 888.3360

Advisory panel

Orthopedic

Date received

1989-10-05

Decision date

1989-12-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Port Huron, MI, US

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Injury

523

Total

523

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0149-2026 — BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55Class II·Ongoing·BioPro, Inc.·20250909

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K895886.